Evaluation of the First Year of a Pilot Program in Community Pharmacy: HIV/AIDS Medication Therapy Management for Medi-Cal Beneficiaries

BACKGROUND: The advent of combined antiretroviral therapy (ART) has increased treatment effectiveness but created new challenges for patients infected with human immunodeficiency virus (HIV) and for community pharmacists managing patients' drug therapy. The ability of pharmacist provided medication therapy management (MTM) services to increase medication adherence, improve health outcomes, and reduce overall medical costs has been demonstrated in community pharmacies for chronic diseases such as diabetes and hypertension. However, the effectiveness of pharmacist-provided MTM services in HIV/acquired immune deficiency syndrome (AIDS) has not been well studied. In January 2005, a pilot program to evaluate MTM services for patients with HIV/AIDS began in California, allowing 10 HIV/AIDS specialty pharmacies to receive compensation for the MTM services that they provided to HIV/AIDS patients. OBJECTIVES: To examine the first year of the HIV/AIDS pharmacy MTM compensation pilot program, which described and compared pilot and nonpilot pharmacies with respect to (a) patient characteristics; (b) intermediate outcomes including type and number of ART medication regimens used, rates of adherence and excess medication fills for ART, use of contraindicated ART regimens, and occurrence of opportunistic infections; and (c) pharmacy and medical costs. METHODS: This was a cohort study examining 2005 Medi-Cal pharmacy and medical claims data for patients with HIV/AIDS who were served by pilot pharmacies versus other pharmacies. The HIV/AIDS patients were Medi-Cal beneficiaries aged 18 years or older as of January 1, 2005, who were continuously enrolled from January 1, 2004, through December 31, 2005, and diagnosed with HIV/AIDS, identified by receipt of at least 1 ART prescription and at least 1 medical claim with a diagnosis (primary or secondary) of HIV/AIDS (ICD-9-CM code 042.0) during both the index period (the year before pilot program implementation, 2004) and the intervention period (the study year, 2005). The only difference in the inclusion criteria for the 2 cohorts was that the pilot pharmacy patients were required to have filled 50% or more of their antiretroviral prescriptions in 2005 at 1 of the 10 pilot pharmacies. Adherence was defined as a medication possession ratio (MPR) of 80%-120% and excess medication fills as MPR greater than 120%. Comparisons were made between groups using bivariate statistics (Pearson chi-square for categorical variables and t-tests for continuous variables). For comparisons of costs, generalized linear models assuming a gamma distribution and log link function were used; predictor variables for the models included age, gender, race/ethnicity, and dual coverage under Medicare. RESULTS: A total of 7,018 HIV/AIDS patients in the Medi-Cal population were identified as meeting the study criteria. Of these, 19.3% (n=1,353) were pilot pharmacy patients. The demographic profile of pilot pharmacy patients was similar, but not identical, to that of patients receiving medications at other pharmacies. A larger percentage of pilot pharmacy patients were on protease inhibitor-based ART medication regimens (63.8% vs. 54.8%, P less than 0.001), remained on a single type of ART therapy throughout the study year (56.8% vs. 34.2%, P less than 0.001), and were classified as adherent (56.3% vs. 38.1%, P less than 0.001), compared with other pharmacy patients. Fewer pilot pharmacy patients used contraindicated regimens (11.6% vs. 16.6%, P less than 0.001) or had excess medication fills (19.7% vs. 44.8%, P less than 0.001). The rate of opportunistic infections did not differ significantly between groups (28.2% vs. 26.1%, P=0.121). The total mean (standard error) annual health care cost per patient was 10% higher in pilot pharmacies than in other pharmacies ($40,596 [$889] vs. $36,937 [$479], P=0.001); driven by use of (a) medications (primarily non-ART medications) and (b) mental health services.

METHODS: This was a cohort study examining 2005 Medi-Cal pharmacy and medical claims data for patients with HIV/AIDS who were served by pilot pharmacies versus other pharmacies. The HIV/AIDS patients were Medi-Cal beneficiaries aged 18 years or older as of January 1, 2005, who were continuously enrolled from January 1, 2004, through December 31, 2005, and diagnosed with HIV/AIDS, identified by receipt of at least 1 ART prescription and at least 1 medical claim with a diagnosis (primary or secondary) of HIV/AIDS (ICD-9-CM code 042.0) during both the index period (the year before pilot program implementation, 2004) and the intervention period (the study year, 2005). The only difference in the inclusion criteria for the 2 cohorts was that the pilot pharmacy patients were required to have filled 50% or more of their antiretroviral prescriptions in 2005 at 1 of the 10 pilot pharmacies. Adherence was defined as a medication possession ratio (MPR) of 80%-120% and excess medication fills as MPR greater than 120%. Comparisons were made between groups using bivariate statistics (Pearson chi-square for categorical variables and t-tests for continuous variables). For comparisons of costs, generalized linear models assuming a gamma distribution and log link function were used; predictor variables for the models included age, gender, race/ethnicity, and dual coverage under Medicare.
RESULTS: A total of 7,018 HIV/AIDS patients in the Medi-Cal population were identified as meeting the study criteria. Of these, 19.3% (n = 1,353) were pilot pharmacy patients. The demographic profile of pilot pharmacy patients was similar, but not identical, to that of patients receiving medications at other pharmacies. A larger percentage of pilot pharmacy patients were on protease inhibitor-based ART medication regimens (63.8% vs. 54.8%, P < 0.001), remained on a single type of ART therapy throughout the study year (56.8% vs. 34.2%, P < 0.001), and were classified as adherent (56.3% vs. 38.1%, P < 0.001), compared with other pharmacy patients. Fewer pilot pharmacy patients used contraindicated regimens (11.6% Evaluation of the First Year of a Pilot Program in Community Pharmacy: HIV/AIDS Medication Therapy Management for Medi-Cal Beneficiaries • The only 2 published studies related to pharmacist-provided MTM services in HIV/AIDS patients both concluded that pharmacist-led interventions had a positive effect on clinical outcomes. However, these studies were small and based in specialized HIV clinics, not community pharmacies. • A chart review study demonstrated improved medication adherence (refilling prescriptions on average every 31 vs. 50 days) and a significantly greater reduction in viral load at 6 and 12 months after initiating therapy (both comparisons P < 0.05) for patients with HIV/AIDS who attended a pharmacist-led medication adherence clinic (n = 80) than for patients not attending. • A prospective study of patients (n = 34) attending a pharmacistmanaged drug optimization clinic reported significant improvement from baseline in CD4 + T-lymphocyte counts (mean [SD] improvement 54 [78] cells per cubic millimeter [mm 3 ], P < 0.001) and viral loads (mean reduction 1.02 log 10 copies per milliliter [mL], P = 0.004). However, that study lacked a comparison group. • Larger studies using pharmacy records have demonstrated that improved adherence was correlated with reduced viral load; for example, for each 10% increase in adherence rate, viral load decreased by 0.12 log 10 copies per mL (95% confidence interval [CI] = 0.01-0.23 log 10 copies per mL), and when adherence fell below 95%, the percentage of patients with viral load below 400 copies per mL fell below 60%. T he advent of combined antiretroviral therapy (ART) has increased treatment effectiveness but created new challenges for patients infected with human immunodeficiency virus (HIV) and for community pharmacists managing patients' drug therapy. Combined ART generally consists of 3 or more HIV drugs taken together from at least 2 of the 3 main drug classes; protease inhibitors (PI), nonnucleoside reverse transcriptase inhibitors (NNRTI); and nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTI). 1 Because the virus can develop resistance against any 1 drug given alone, at least 3 or more drugs, usually from 2 or more different classes, must be used at the same time. Treatment regimens containing a PI are typically among the most potent and/or durable against the virus, but often have the least tolerable side effects. Complex ART regimens contain multiple drugs with various dosing schedules, undesirable side effect profiles, and different storage requirements for many of the medications. 2 Strict adherence to HIV drug therapy has been shown to be crucial to achieving optimal therapeutic outcomes such as reduced viral load, reduction of drug resistance, and improved survival. [3][4][5] The potential of pharmacist-provided medication therapy management (MTM) services to increase medication adherence, improve health outcomes, and reduce overall medical costs has been demonstrated in community pharmacies for chronic diseases such as diabetes and hypertension. 6,7 However, the effectiveness of pharmacist-provided MTM services in HIV/acquired immune deficiency syndrome (AIDS) has not been well studied. A review of the literature found only 2 studies that described the type of MTM services provided by a pharmacist and assessed outcomes. Both studies were conducted in HIV outpatient clinics. The first, a chart review study, demonstrated improved medication adherence (refilling prescriptions on average every 31 vs. 50 days, P < 0.05) and a significantly greater reduction in viral load at 6 and 12 months (P < 0.05) after initiating therapy for patients attending a pharmacist-led medication adherence clinic and at least 1 educational session from the clinical pharmacist (n = 80) versus those not attending (n for comparison group not reported). 8 The second, a prospective study of patients (n = 34) who had an extensive history of treatment and attended a pharmacist-managed drug optimization clinic, reported significant improvement from baseline in CD4 + T-lymphocyte counts (mean [SD] improvement 54 [78] cells per cubic millimeter [mm 3 ]; P < 0.001) and viral loads (mean reduction 1.02 log 10 copies per milliliter [mL]; P = 0.004). 9 A significant decrease in the mean drug-related toxicity score was also observed among patients experiencing drug-related toxicities (n = 25, mean [SD] reduction of 1.0 [0.8] on the 4-point Radiation Therapy Oncology Group common toxicity scale, P < 0.001). However, that study lacked a comparison group.
Although not including a MTM services component, several studies have shown significant correlation between improved medication adherence, as measured by pharmacy data, and reduced viral load. [10][11][12] For example, Grossberg et al. reported that, for each 10% increase in adherence rate, viral load decreased by 0.12 log 10 copies per mL (95% confidence interval = 0.01-0.23 log 10 copies per mL) and Fairley et al. reported that, when adherence fell below 95%, the percentage of patients with viral load consistently below 400 copies per mL fell below 60%. 11,12 It is reasonable to expect that the provision of MTM services would increase adherence, as it has in other disease states, and thus reduce viral load. However, barriers to the delivery of specialized counseling services to enhance adherence in HIV/AIDS patients in community pharmacy settings have also been recognized. For example, in a statewide survey of pharmacists in North Carolina, 59% of community pharmacist respondents indicated that they did not have enough time to provide adherence counseling to their HIV/AIDS patients. 13

Pilot Program Description
In January 2005, a pilot program to compensate and evaluate community pharmacy-based MTM services for patients with HIV/AIDS began in the state of California. This program, under Welfare and Institutions Code Section 14199-14199.3, allowed 10 HIV/AIDS specialty pharmacies in the state to receive compensation for the MTM services that they provided to HIV/AIDS Medi-Cal patients. The California Department of Health Care Services (DHCS) provided pilot pharmacies $9.50 per prescription dispensed to a Medi-Cal beneficiary for the 3-year term of the pilot program. The DHCS selected the 10 pilot pharmacies based on the requirements of the legislation authorizing the pilot. 14 The first 10 pharmacies that applied and met the following criteria

What this study adds
were selected: (a) patient population comprising 90% or more of persons with HIV/AIDS, (b) had the ability to immediately provide specialized services rendered by a qualified pharmacist or other health care provider operating within his or her scope of practice, and (c) had pharmacists and other qualified health care providers to identify patients who should receive MTM services. Specialized services were defined as being distinct from generalized patient education and information activities already required by law and provided for in the professional dispensing fee. These services (a) were to be patient specific and individualized services provided directly by a pharmacist to the patient or, in limited circumstances, the patient's caregiver, and (b) involved face-to-face interaction between the patient or caregiver and the pharmacist during delivery of MTM services. The possible types of MTM services outlined in the legislation were based on the definition of MTM services published by the American Pharmacists Association. 15 Patients of pilot pharmacies chose to patronize pilot pharmacies either through their own selection process and/or based on physician referral; these decisions were made independent of this study. Following up on previous work suggesting a potential impact of pharmacist-provided MTM services on adherence and viral load in HIV/AIDS patients who were treated in the community setting, 8,9 the California HIV/AIDS pharmacy MTM services pilot program provided an opportunity to investigate a broader range of outcomes using a larger sample of patients with HIV/AIDS. The California study examined patients receiving care at pharmacies providing a wide range of MTM services and compared their outcomes with those of similar patients at other pharmacies throughout the state.

Study Objectives
The purpose of this study was to examine the first year of the HIV/AIDS pharmacy MTM services compensation pilot program. The study used pharmacy and medical claims data to describe and compare patients filling prescriptions at pilot (MTM) versus other pharmacies with respect to (a) patient characteristics; (b) intermediate outcomes, including the number and type of ART medication regimens, rates of adherence and excessive fills, use of contraindicated ART regimens, and occurrence of opportunistic infections; and (c) pharmacy and medical costs.

■■ Methods Description of the Intervention
The intervention in this study was participation in the DHCS compensation pilot program for MTM services. The program required that participating pharmacies be able to immediately offer MTM services; therefore, pharmacies selected for the pilot compensation program had been offering a range of MTM services before participating. Although the specific services that each pilot pharmacy must provide were not defined, all pilot pharmacies offered services to (a) manage adverse drug reactions and medication side effects; (b) evaluate patient ability to adhere to medication regimens, in consultation with physicians and case managers; and (c) tailor drug regimens to accommodate specific patient needs. 16 Each pharmacy worked with patients and/or their physicians according to their own practice norms, and further details were not available to the researchers.

Outcome Measures
Provision of MTM services in pilot pharmacies was expected to (a) improve adherence to ART regimens, (b) result in more rational ART medication strategies (e.g., fewer contraindicated regimens, fewer medication changes per year which can decrease likelihood of developing drug resistance), (c) decrease occurrence of opportunistic infections, and (d) reduce costs through more rational medication usage and reduced need for medical services. Ten outcome measures were assessed (Table 1). Patients were identified as pilot pharmacy patients if they had filled 50% or more of their ART prescriptions in 2005 at 1 of the 10 pilot pharmacies. Comparison group patients met the same inclusion and exclusion criteria as study patients, except that they were not identified as having filled 50% or more of their ART prescriptions in 2005 at 1 of the 10 pilot pharmacies. Individuals enrolled in managed care plans were excluded because paid claims are not generated for Medi-Cal participants enrolled in managed care.

Data Analysis
Descriptive statistics were calculated for all variables. Frequency distributions were used to describe categorical variables, and means, medians, standard deviations, and ranges were used for continuous variables. Gender, dual coverage under Medicare, race/ethnicity, ART adherence and ART medication category were expressed as percentages, and differences between groups (pilot versus other pharmacy patients) were assessed using the Pearson chi-square test. Age and number of pharmacy visits to fill ART prescriptions were expressed as means, and differences between groups were assessed using t-tests. Differences in costs were analyzed using generalized linear models assuming a gamma distribution and log link function; predictor variables for the models included age, gender, race/ethnicity, and dual coverage under Medicare. 17,18 Standardized estimates of costs were calculated for pilot and nonpilot pharmacies. Standard errors were calculated using the nonparametric bootstrap, and P values were calculated using the percentile method. DHCS payments to pilot pharmacies, $9.50 per prescription dispensed for any medication (not just ART drugs), were not included in the cost estimates and are presented separately. Statistical significance was set at P < 0.05. All statistical analyses were performed using Stata version 9.2 (Stata Corp., College Station, TX).

Medi-Cal HIV/AIDS Patients (Pilot and Other Pharmacy Patients Combined)
The study population consisted of 7,018 patients meeting the study inclusion criteria (Figure 1). Patients had a mean (SD) age of 46.5 (8.8) years, were predominantly male (80.1%), and slightly more than one-half (53.3%) had dual coverage with Medicare during 2005. The largest proportion of patients was white (46.2%), with African-American and Latino patients comprising 25.9% and 19.5% of the population, respectively.
The mean (SD) number of pharmacy visits to fill ART prescriptions during 2005 was 14.4 (8.0). More than 80% of fills were for a 30-day supply. Approximately 18% of patients were either nonadherent or only partially adherent to their ART medications. Almost equal proportions were adherent (41.6%) or had excess fills (40.0%). When classified by the type and number of ART medications received, the largest percentage (56.5%) of patients were taking a PI-based regimen (N(t)RTIs + PI ± NNRTI). The remainder of patients were on regimens not containing a PI; an NNRTI-based regimen (N(t)RTIs + NNRTI) (29.9%) or less potent multiple N(t)RTIs (11.4%). A small percentage (2.2%) of patients were on a single N(t)RTI, a treatment strategy that is not recommended.
Total annual medication cost per patient averaged (SD) $25,254 ($18,692). The largest proportion of total medication cost was for ART, which averaged $16,195 ($8,217) per patient. The difference between total and ART cost was attributable to non-ART outpatient medications.

Pilot Versus Other Pharmacy Patients
Approximately 20% of the study population received the majority of their prescription medications at a pilot pharmacy in 2005 (Table 2). Compared with nonpilot pharmacy patients, pilot pharmacy patients were slightly younger (mean 46.0 vs. 46.7 years, P = 0.016). The proportion of pilot pharmacy patients who were male (76.3%) or had dual Medicare coverage (48.6%) was less than in the nonpilot pharmacy group (81.0% and 54.4%, respectively; P < 0.001). The pilot pharmacy group had a larger proportion of African-American patients, compared with the nonpilot group (29.4% vs. 25.2%, respectively; P = 0.001), and a smaller percentage of Latino patients (17.6% vs. 19.9%, respectively; P = 0.050).
Patients of pilot pharmacies had a greater mean [SD] number of pharmacy visits to fill ART prescriptions, compared with nonpilot pharmacy patients (15.4 [10.5] vs. 14.1 [7.3], respectively; P < 0.001); however, the median number of visits was 13 in both groups (Table 3). Comparing patients in the pilot pharmacy group with those served by other pharmacies, the percentage of patients classified as adherent was significantly greater (56.3% vs. 38.1%, P < 0.001) and the percentage of patients with excess fills was much smaller (19.7% vs. 44.8%, P < 0.001). A significantly greater number of pilot pharmacy patients were classified as nonadherent or partially adherent, compared with other pharmacy patients, although the magnitude of difference was 4 percentage points or less (P < 0.001).
A significantly greater percentage of pilot pharmacy patients  (63.8%) were on a PI-based ART regimen (N(t)RTIs + PI ± NNRTI), compared with other pharmacy patients (54.8%), P < 0.001 (Table 3). The percentage of pilot pharmacy patients on less potent combination regimens was significantly smaller for each category as compared with other pharmacy patients. A significantly smaller percentage of pilot pharmacy patients (1.0%) were on the nonrecommended single N(t)RTI treatment strategy, compared with other pharmacy patients (2.4%; P < 0.001).

Evaluation of the First Year of a Pilot Program in Community Pharmacy: HIV/AIDS Medication Therapy Management for Medi-Cal Beneficiaries
A smaller percentage of pilot pharmacy patients were on contraindicated ART regimens as compared with other pharmacy patients (11.6% vs. 16.6%, respectively; P < 0.001) ( Table 3). Identified contraindications included all of those screened ( Table  1), except that no patients had stavudine plus zidovudine, or saquinavir as a single agent. Pilot pharmacy patients were also significantly less likely to change their medication regimen strategy compared with patients in other pharmacies (P < 0.001). For example, 56.8% of pilot pharmacy patients were able to remain on one ART regimen strategy throughout the year, compared with only 34.2% of other pharmacy patients. Almost one-quarter of other pharmacy patients used 3 or more regimen strategies during the study year, compared with only 10.8% of the pilot pharmacy patients. No significant difference in the number of patients experiencing opportunistic infections was detected between pilot and other pharmacy patients (P = 0.121).
The   The greater percentage of adherent patients in pilot pharmacies is consistent with findings from the Cantwell-McNelis and James (2002) study of HIV/AIDS patients attending a pharmacist-led medication adherence clinic that demonstrated improved medication adherence and decreased viral load for patients attending the clinic over a 1-year period versus those not attending. 8 Although our study was not able to include clinical outcomes (e.g., viral load) it would be reasonable to expect that the improved adherence observed in pilot pharmacy patients will translate to improved clinical outcomes given the results of large studies using pharmacy records that have demonstrated that improved adherence is correlated with reduced viral load. [10][11][12] In the present study, the age, gender, and race/ethnicity mix of the entire study population of HIV/AIDS Medi-Cal patients was fairly similar to that observed in 2 studies of California HIV/ AIDS patients; one (Purdum et al., 2004) described the HIV/ AIDS population of Kaiser California and another an HIV/AIDS nurse case-management program with pharmacy support in the inner city of San Francisco. 19,20 Thus, our overall study population appears to be similar to that in California. In the present study, the pilot pharmacy group was slightly younger, had a lower percentage of males and Medicare dual-eligible patients, and a higher percentage of African-American patients than did the cohort of patients filling ART prescriptions at other pharmacies. Although these differences were statistically significant the magnitude of difference for each was small. Therefore, the demographic profile of HIV/AIDS patients receiving medications at pilot pharmacies was generally similar to that of HIV/AIDS patients receiving medications at nonpilot pharmacies across the state.

Evaluation of the First Year of a Pilot Program in Community Pharmacy: HIV/AIDS Medication Therapy Management for Medi-Cal Beneficiaries
The proportion of patients experiencing opportunistic infections during this study year was low, and similar, for both groups.

■■ Discussion
This article describes the initial evaluation of a novel community pharmacy-based MTM compensation program for patients enrolled in Medi-Cal and diagnosed with HIV/AIDS. To our knowledge, this is the first large-scale MTM program and evaluation of its kind in patients with HIV/AIDS. The results showed that a larger percentage of pilot pharmacy patients were on PI-based ART medication regimens. Although these regimens often have more side effects, pilot pharmacy patients had a greater adherence rate and fewer ART regimen changes than did nonpilot pharmacy patients. Fewer pilot pharmacy patients were on contraindicated regimens or had excess medication fills. The rate of opportunistic infections did not differ significantly between groups. The total annual cost per patient was 10% higher in pilot pharmacies. The difference was attributable to higher medication costs (largely non-ART) and greater use of mental health services by pilot pharmacy patients. Payment from California DHCS for MTM services averaged $1,014 per pilot pharmacy study patient ($183 per patient considering all patients using pilot pharmacies). The proportion of patients who were partially adherent or nonadherent in both groups is troublesome because these patients are at greater risk of developing resistance that could affect their longer-term therapy options. Future evaluation will investigate if the rates of opportunistic infections and nonadherence change during the subsequent 2 years of the pilot program.

Evaluation of the First Year of a Pilot Program in Community Pharmacy: HIV/AIDS Medication Therapy Management for Medi-Cal Beneficiaries
One finding deserves special emphasis. The majority of pilot pharmacy patients remained on a single type of medication regimen strategy for the year studied, compared with patients of other pharmacies, who changed their medication regimen type more often. Even though combined ART treatment has proven effective against HIV, one of the key limitations is that the virus becomes resistant to the available drugs. The more drugs and the more drug classes that a patient is exposed to increases the likelihood of developing drug resistance. Patients who need to switch regimens often (either due to lack of efficacy or intolerance or inability to manage side effects) are essentially exhausting their future treatment options and will not remain as healthy or live as long as patients who are successful on a single regimen for as long as possible. Because the pilot pharmacy patients were able to use and stay on a potent PI-based regimen more often than the patients filling ART prescriptions at other pharmacies, the expectation is that the pilot pharmacy patients will maintain their health and live longer.
The average total cost per patient in the pilot pharmacy group was approximately 10% greater than in the other pharmacy group. Medi-Cal was the only payer in the study; therefore reimbursement rates for services and products were equal between groups (although minor variation can occur because of differences in claim amounts submitted). Thus, differences in expenditures reflected differences in utilization rates or mix of products and services. The higher cost was attributable to greater utilization of medications (largely non-ART) and mental health services.
Although statistically significant, the magnitude of difference in average ART medication cost per patient between pilot and other pharmacies was small, $570 per patient per year (3.5%). However, pilot-pharmacy patients had a greater number of pharmacy visits to fill prescriptions and higher total medication cost due mostly to non-ART medication usage. Pilot patients used more antiemetics, analgesics and anticonvulsants. These medications are commonly used in HIV/AIDS patients to treat side effects of ART medications such as nausea and pain of peripheral neuropathy. This finding is consistent with that of March et al. who reported a positive effect of pharmacist MTM services on medication side effects, expressed in their study as a reduction in drug-related toxicities. 9 In addition to treating side effects, the pilot pharmacy patients appear to receive more medications for psychiatric comorbidities, which is consistent with the increased expenditures on mental health services. These findings suggest that the pilot pharmacy patients may receive more appropriate HIV treatment and perhaps more comprehensive medical access and care for their other conditions, often related to their primary therapy.
There remains a need to determine the ultimate long-term benefit of patients being more adherent on appropriate combined ART regimens and using more non-ART medications and mental health services over several years. Possible savings in more costly inpatient care will be investigated when data for subsequent years of the pilot program are available. These longer-term data also will allow investigation of the cost-effectiveness of the $9.50 per prescription payments for MTM services by the California DHCS. However, with the advent of Medicare Part D, the dualeligible Medicare patients will no longer receive medications through Medi-Cal and thus will not be available for follow-up. However, the results of this pilot may help Medicare Part D plans understand the value of community pharmacists providing MTM services to HIV/AIDS patients; especially Medicare Special Needs Plans focusing on this patient population.

Limitations
The foremost limitation of this study is that it is an evaluation of an ongoing program and may be subject to selection bias due to nonrandom assignment of HIV/AIDS patients to pharmacies. If patients who fill their prescriptions at pilot pharmacies are different from patients who fill their prescriptions at other pharmacies, then the pilot pharmacy estimated effect will include both the true pilot program effect and the baseline differential between patients. Although the 2 patient groups appeared to be similar with regard to observable variables (e.g., age, gender), nonobservable variables (e.g., willingness to follow treatment protocols, possible physician referral of more complicated patients to pilot pharmacies) may differ between groups and affect conclusions. Second, it is possible that some of the other (comparison cohort) pharmacies provided some of the same services as the pilot pharmacies, because only the first 10 pharmacies meeting program criteria were enrolled in the pilot compensation program.
Third, an inherent limitation to this analysis is its reliance on Medi-Cal retrospective claims data that do not include clinical outcomes such as viral load and CD4 counts.
Fourth, our results are relevant to California but may not reflect what would occur with a similar MTM program in patient populations with different demographic or disease characteristics. Fifth, comparison of patient outcomes and costs before and after MTM services were initiated by pilot pharmacies was not possible because the pilot pharmacies provided MTM-like specialty services for varying amounts of time before receiving the compensation from the pilot program. Finally, this was an analysis of only the first year of the pharmacy compensation pilot program. Claims data from subsequent years of the pilot program are being sought to determine whether observed differences in outcomes and treatment costs continue to be observed over the 3-year period of the pilot program.

■■ Conclusions
Patients at pilot pharmacies appear to benefit from more specialized and patient-specific MTM services offered by pilot pharmacies. Pilot pharmacy patients were on more potent ART regimens, had higher medication adherence rates, fewer excess fills, and fewer contraindicated regimens than nonpilot pharmacy patients. Importantly, more pilot pharmacy patients remained on a single type of ART regimen throughout the study year, which decreases the likelihood of developing drug resistance and enhances the ability to maintain health over a longer period of time. Total cost per patient was 10% higher in pilot pharmacies, with the higher cost attributed to non-ART medications and mental health services. Longer-term outcomes and costs of the pilot program will be examined when data for subsequent years are available.

DISCLOSURES
Payment to pharmacies participating in the pilot program for MTM services was funded by the state of California. There was no other external funding for this research. Teresa Miller is employed by the California Department of Health Care Services as Senior Consulting Pharmacist, Medi-Cal Pharmacy Policy Branch, California Department of Health Care Services. Her department has responsibility for implementing the pilot MTM services program subsequent to the enacted legislation.